Authority to Sell Veterinary Drug Fees

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Contact: Submission and Information Policy Division (SIPD) Annual

Pursuant to Section C.01.014.5 of Food and Drug Regulations, every year Health Canada sends an Annual Drug Notification Form to the Drug Identification Number (DIN) owner of drugs that are currently being marketed in Canada. The Annual Drug Notification Form contains a list of those products that, according to Health Canada records, have been issued DINs, have subsequently been notified for sale and have not been discontinued by the DIN owner.

The completed Annual Drug Notification Form with any requests for fee reduction should be submitted to Health Canada no later than mid August of that year. This allows sufficient time for fee reduction to be validated, updated, and reflected on the invoice which is issued October 1 for payment within 30 days. This process minimizes the administrative burden to both DIN owners and to Health Canada staff by eliminating the need for later invoice adjustments and the confusion caused by inaccurate accounts statements.

The annual fee for the Authority to Sell Veterinary Drug for which a DIN has been assigned is $250.00. The fee is payable annually at the time the manufacturer furnishes the Annual Drug Notification Form before October 1 in accordance with section C.01.014.5 of the Food and Drug Regulations. The fee is paid in advance of the year that it covers. For example, fees paid on October 1, 2011 cover the authority to sell from October 1, 2011 to September 30, 2012.

Who is Eligible for a Fee Reduction?

A veterinary product qualifies for a reduced fee of $50.00 ($CDN) if its wholesale sales were less than $20,000 ($CDN) during the company's previous fiscal year that was completed in the 12-month period before October 1st of the invoicing year. Since fees are charged at the beginning of the invoicing year, fee reductions are granted based on sales data of the company's previous fiscal year. Products for which the DIN has been discontinued are not eligible for a fee reduction as no fee is charged for non-marketed DINs.

In order to be granted a fee reduction the manufacturer must provide, a completed Authority to Sell Veterinary Drugs Fee Reduction Request and Attestation From, with their completed Annual Drug Notification Form. The form must be signed by an authorized officer of the company. Note that fee reductions will NOT be processed without this form.

DIN owners outside Canada must determine their eligibility by using their annual wholesale sales of the drug in Canada. Therefore, if the DIN owner sells the drug through more than one importer, in Canada, the reduction is based on the actual gross revenue that the DIN owner receives from the sales of all importers of the drug in Canada.

If any company does not return their annual drug notification form, full fees will be charged for all of their marketed notified DINs in Canada. Also, any fee reduction request will not be accepted after invoices have been sent out.

Who is Responsible for Payment?

The person on record as owning the DIN when the invoice is issued is responsible for payment. The invoice and any subsequent monthly statements are prepared in the name of the DIN owner and are sent to the regulatory affairs section of the company or address identified as the billing address for the DIN owner on the returned Annual Drug Notification Form.

If a new DIN has been assigned to a product in order to replace an existing notified product, but the previous DIN has not been discontinued by its owner, the owner of each DIN is held responsible for payment of an annual fee, whether or not the previous DIN is still available on the Canadian market. For example, where the ownership of a product has been transferred to another company and the new owner has received a new DIN, an annual fee will be applied to both the old DIN and the new DIN if both are on Health Canada records as being marketed.

When to Pay Fees?

Fees are to be paid within 30 days of the date on the invoice. Invoices are issued on October 1^st of each year. Please do not submit fees before the invoice is issued.

Where to Submit Annual Drug Notification Form?

Annual Drug Notification Form and Fee Reduction requests should be sent to the address/fax number/e-mail below:

By mail: Submission and Information Policy Division
Therapeutic Products Directorate
Health Canada
Finance Building
101 Tunney's Pasture Driveway, Address Locator 0201A1
Ottawa, Ontario
K1A 0K9

By Fax: (613) 954-3067

By E-Mail: sipdannual_annuelledppr@hc-sc.gc.ca